The president urged the FDA to make hearing aids available over the counter last year in his executive order Promoting Competition in the American Economy to reduce costs and increase competition in certain industries.
The new regulations will create a new category of hearing aids that replace state-level regulations that require patients to visit doctors or audiologists to obtain prescriptions and fittings. The devices will be available to people aged 18 and over with mild to moderate hearing loss at pharmacies, shops and online.
Sen. Elizabeth Warren (D-Mass.), a co-sponsor of the Over-the-Counter Hearing Aid Act, praised the decision on Twitter and credited Biden with moving the issue forward after it stalled at the FDA.
“It took years of hard work, but I’m glad that millions of Americans — many of whom don’t use hearing aids because they’re too expensive — will soon be able to buy safe and affordable hearing aids over the counter,” she tweeted. “This is what it looks like when the government works for working people.”
The change is expected to significantly benefit older adults — people who are most likely to experience hearing loss and have a fixed income — as well as those in poor and rural communities who have fewer audiologists.
The move comes more than four years after Congress ordered the FDA to create regulations for over-the-counter devices.
Hearing aids without a prescription or examination? The FDA is taking a big step toward making that happen.
“This rule is expected to help us achieve quality and affordable access to health care for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra said. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
The current cost of hearing aids averages more than $5,000 per pair, and they are typically not covered by traditional Medicare or other insurance companies. Vice President Harris said the rule would reduce the cost of hearing aids by hundreds and even thousands of dollars.
“Every American has the right to receive affordable health care,” she said in a statement Tuesday. “Today, our administration has taken another step forward in our fight to protect that right.”
A study published in Social Science and Medicine in 2019 found that the counties with the largest numbers of older adults with hearing loss often had fewer audiologists available, in part because the doctors tend to practice in younger, wealthier urban areas.
Stigma, lack of access and confusion about how to get the best health care often keep people — especially older Americans — from taking care of their hearing health, said Barbara Kelley, executive director of the Hearing Loss Association of America. This option will benefit countless Americans who may need hearing assistance in perhaps restaurants or large family gatherings without necessarily seeking a hearing specialist, she said.
“For years, we’ve worked for affordable and accessible hearing health care, and this is a big step in getting people to pay attention to their hearing health sooner rather than later,” Kelley said. “And this just provides another path — a really new path — for adults with mild to moderate hearing loss who can take a step on their own.”
Although about 38 million adults in the United States report hearing loss, few have tried the devices. Among adults over 70 with hearing loss, only one in three have ever used one, according to data collected in the National Health Interview Survey.
The FDA’s move follows years of federal efforts to remove barriers between patients and over-the-counter hearing aids. In 2015, the President’s Council on Science and Technology under Barack Obama recommended that the FDA create a new category of “basic” hearing aids that can be purchased without a prescription or a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, giving the FDA three years to adopt the new rules.
The FDA missed that deadline in 2020, but President Biden renewed the push in July 2021 when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.